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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
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`Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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`NDA 21992/S-013
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`Wyeth Pharmaceuticals, Inc.
` Attention: Lauren E. Washam
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`Regulatory Specialist I
`Worldwide Regulatory Strategy
`PO Box 8299
`Philadelphia, PA 19101-8299
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`Dear Ms. Washam:
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`Please refer to your supplemental new drug application dated March 16, 2010, submitted under
`section 505(b) of the Federal Food, Drug, and Cosmetic Act for Pristiq (desvenlafaxine)
`Extended-Release Tablets.
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`We acknowledge receipt of your amendment dated July 8, 2010.
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`The July 8, 2010, submission constituted a complete response to our May 19, 2010, action letter.
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`This Prior Approval supplement provides for revisions to the Medication Guide concerning
`NMS-like reactions contained in Section 5.2 entitled Serotonin Syndrome or Neuroleptic
`Malignant Syndrome (NMS)-like Reactions of the presciber labeling.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling [21 CFR
`314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert and Medication Guide) and include
`the labeling changes proposed in any pending “Changes Being Effected” (CBE) supplements.
`Information on submitting SPL files using eLIST may be found in the guidance for industry
`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications for this NDA, including
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`NDA 21992/S-013
`Page 2
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`pending “Changes Being Effected” (CBE) supplements, for which FDA has not yet issued an
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format that
`includes the changes approved in this supplemental application.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, email Juliette Touré, PharmD, Senior Regulatory Project Manager, at
`Juliette.Toure@fda.hhs.gov.
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`Sincerely,
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` {See appended electronic signature page}
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`Thomas Laughren, M.D.
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`Director
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Enclosure: Content of Labeling
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`THOMAS P LAUGHREN
`10/18/2010
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`Reference ID: 2851106
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